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Surgical Technique Guide Humerus, Radius & Ulna

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Surgical Technique Guide Humerus, Radius & Ulna ® Surgical Technique Guide Humerus, Radius & Ulna Table of Contents System Description & Indication for Use 1 Pre-Operative Setup 1 Humerus Surgical Approach 2 Distal Radius Surgical Approach 5 Ulna Surgical Approach 6 Component Preparation 6 Balloon Catheter Priming and Preparation 7 Sheath Assembly and Delivery within the Canal 8 Balloon Catheter Insertion and Monomer Infusion 8 Handling of the Light Fiber & Curing Cycle 9 Separation of Catheter from Implant 10 Screw Placement (optional) 11 Post-Operative Management 11 Implant Removal 11 Appendix A: Light Box Preparation 12 Appendix B: Liquid Monomer Removal Process 13 Indication for Use, Cautions, Contraindications, Warnings & Risks 14 MRI Safety Information 15 Appendix C: Instrumentation 16 Implants, Guidewires, Sheaths and Dilators 17 Indication for use: The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA cleared fracture fixation system to provide supplemental fixation in the humerus, radius and ulna. During a percutaneous procedure, a small diameter expandable balloon catheter is inserted into the medullary canal and is positioned across the area requiring stabilization. Once in correct alignment and position, it is infused with a biocompatible light curable liquid monomer, which hardens under the application of blue visible light. The monomer is cured and remains within the PET balloon, which conforms to the anatomic contours of the medullary canal making it a customized intramedullary rod, providing longitudinal and rotational stability. The IlluminOss Photodynamic Bone Stabilization Procedure Pack, its container, and any packaging is not made with natural rubber latex. 1. System Description The IlluminOss Photodynamic Bone Stabilization System is comprised of a single use disposable procedure pack, along with a reusable curing system (Figures 1-3) and instrument set (Appendix C). Surgical stabilization is recommended for patients at risk for fracture and in whom stable fixation can be achieved with an intramedullary implant. During a percutaneous procedure, a small diameter expandable balloon catheter is inserted into the medullary canal and is positioned across the area requiring stabilization. Once in correct alignment and position, it is infused with a biocompatible light curable liquid monomer which hardens under the application of visible (436 nm) light. The monomer is cured and remains within the PET balloon, which conforms to the anatomic contours of the medullary canal making it a customized intramedullary rod, providing longitudinal and rotational stability to the affected bone. Figure 1 This section provides key or important information about the use of the product in the treatment of traumatic, fragility, pathological and impending pathological fractures of the humerus, radius and ulna. NOTE: The following document does not attempt to discern between different types of cancers, fractures, anatomic locations and or treatment Figure 2 options associated with specific disease states. The information contained within should not constrain nor restrict medical judgment and is not intended to impinge upon the practice of medicine. It is instead intended to augment the professional skills of the surgeon and to serve as a ready reference source in the use of the product. The IlluminOss implant can be used for either the right or the left Figure 3 humerus, radius or ulna. Indication for Use The IlluminOss Photodynamic Bone Stabilization System is indicated for the use in skeletally mature patients in the treatment of traumatic, fragility, pathological and impending pathological fractures of the humerus, radius and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius and ulna. Implant Sizes IlluminOss implants range in diameter from 7.0mm to 22.0mm and in lengths from 70mm to 280mm. For currently available sizes refer to Table 1 on page 17. Contraindications This product is contraindicated in patients who have an active or incompletely treated infection that could involve the site where the device will be implanted; are allergic to any of the implant materials or to dental glue; have an intramedullary canal measuring smaller than the diameters of the delivery sheath provided with the implant; at the site of the fracture; distant foci of infections which may spread to the implant site, have open fractures with severe contamination; or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment. 2. Pre-Operative Set-up Ensure that the appropriate instrumentation kits (Delivery and/or Humerus Specific) have been sterilized and are delivered to the OR suite (see Appendix C for instrumentation detail). Ensure that a sufficient range of implants are brought to the OR suite as well as ancillary guidewires and sheaths. Set-up and activate the light box prior to the start of the procedure to ensure operation. (See Appendix A: Light Box Preparation) or the light box specific instructions for use PN #900368 for more detailed information on the lightbox. NOTE: The light box must be set up outside the sterile field and should be on the same side as the target site to be treated. | SURGICAL TECHNIQUE | 1 Implant Sizing Implant sizing may be done pre-operatively or after the start of the procedure. Determine Implant Length In cases of impending fracture the approximate implant length can be determined pre-operatively. If the arm is fractured, the correct length can only be determined if the fracture is correctly reduced. • Position the image intensifier for an A/P view of the humerus, radius or ulna. For Humerus: • Measure the length of the humerus from its head to the olecranon fossa and deduct 3 cm from the measured distance. • Hold a radiographic ruler parallel to the humerus with one end at the proximal humerus. Mark the skin at the proximal end of the ruler. • Position the image intensifier over the distal humerus, place the proximal end of the ruler next to the marked skin site and record an A/P image. For Radius & Ulna: • Measure the radius from the radial styloid to the fracture site. • Measure the ulna from the entry point to the fracture. • Check the reduction and read off the length from the illustration on the ruler. Determine Implant Diameter • Position the image intensifier for views of the affected bone in two planes. • It is important to view and to measure the bone in two planes so that the largest diameter of the canal can accurately be determined and the correct sized implant chosen. • An undersized implant not achieving circumferential cortical contact will not be stable. • Hold the ruler parallel at right angles to the affected bone while positioned over the medullary canal. • Select the implant diameter sufficient to fill and to achieve contact with the medullary canal/cortex. • Alternatively utilizing pre-operative radiographic films, and embedded software in the x-ray programs, measurements for the implant length and diameter can be made in accordance with the individual’s x-ray systems. General Consideration Points • WARNING: Fracture stabilization cannot be assured when the IlluminOss implant is not in contact with the cortical wall or if the implant is moving within the intramedullary canal. The implant diameter should be of sufficient size so that it achieves circumferential conformal contact with the walls of the intramedullary canal. Select a balloon diameter equal to or slightly larger than the largest canal diameter observed. • In cases where there may be some doubt on the correct diameter implant (e.g. eccentrically shaped canal), always use the next larger size diameter implant. • Reduce the fracture prior to the placement of the implant; the inflation of the IlluminOss implant will not reduce a fracture. • Do not attempt to reduce a fracture or adjust the rotational alignment with an implant inflated and in contact with the cortical walls as this may cause a tear in the implant. Reduce the volume of an implant by withdrawing some of the monomer prior to adjusting the reduction. • The IlluminOss implant is constructed from a thin wall PET balloon. Do not bring instruments (K wires, screws, suture needles, clamps or other instruments) to come in contact with the implant prior to it being fully cured as it may damage or compromise the implant. Humerus Patient Positioning & Surgical Approach For purposes of illustration, a proximal humeral lesion (Figure 4) is described. The Humerus is approached through a minimally invasive deltoid incision to allow for the delivery of an 8 mm cannulated awl to access the canal (Figure 5). Figure 4 Figure 5 2 | SURGICAL TECHNIQUE | A. Humerus Fracture Reduction, Incision & Anatomical Landmarks • Use of reduction clamps to achieve and maintain anatomical reduction of the fracture is recommended in complex fracture patterns. • Make the initial minimally invasive stab incision to allow for the delivery of an 8mm cannulated awl into the head of the proximal humerus. Figure 6 • Alternatively make an incision anterolateral to the acromion process and split the deltoid muscle longitudinally. • The deltoid is split to expose the sub deltoid bursa.
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